Advancements in the medical field are being made faster and faster in this day and age, especially in the wake of the covid 19 pandemic and the looming threat of monkeypox and other infectious diseases. What a lot of us do not realize, though, is that new and lifesaving medicines and procedures can not be done until there are a series of trials for them. How does that work?
The Food and Drug Administration in the United States of America has a series of guidelines laid out for what must be done for a drug to be approved. You can take a peek at some of that here, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents, though the ones interested in participating probably do not need to know all of that. Rather, it helps to offer some perspective on why they occur in the first place.
If this is something that has interested you, but you have been wary of them, you are not alone. It can be scary to participate in the trial stage of a new medicine, especially given their past reputation. However, if we start to research the topic, we will see that there are a lot of protocols in place that protect participants.
Participant Protection Measures
I am starting out here, since this is the biggest point that clinical trials have in their favor right now. In the past, it is no secret that a lot of unethical practices occurred in many of them. There are even documentaries about it and some of the awful things that happened.
However, when we examine how they operate today, the story is actually a lot different. There are in fact laws in place that are meant to protect those who enter any studies like this. What are some examples of this?
For one thing, each one has an investigator assigned to ensure the safety of every single participant involved. They also look at who runs clinical trials to keep track of the goals and the procedures that are meant to be followed. You see, each proctor must submit a list of procedures for the experiment and overall trial.
These are in addition to the rules established by the federal government, and rest assured that they are taken very seriously by researchers. If they were not, there could be serious consequences for that laboratory. However, human decency is often the main motivator for following the rules, thankfully.
As a final note here, there is also an Institutional Review Board here in the United States that reviews each proposed trial and determines whether it can be completed as proposed. Often, they go through several iterations until this committee is satisfied.
Are There Risks?
While researchers and the government both do everything in their power to keep the participants in these trials safe, there are always going to be inherent risks involved when trying drugs or other substances that are previously untested on humans. Sure, there are usually animal tests to make sure that you will not immediately keel over, but it would not be entirely fair to say there were zero risks. That is simply not the case.
In terms of what they look like, that of course will vary depending on the sort of study that you seek to be a part of. You can see some examples of this in this breakdown on the topic. There are a lot of different kinds of trials you could participate in.
Getting a bit more specific with these downsides, you might experience side effects. They could range from mildly uncomfortable to quite severe. It is always important to keep your physicians informed about changes you are experiencing, and relay that information to the researchers as well. These are the reasons that we have trials before launching them on a large scale, after all.
In addition to that, if you are testing out some sort of treatment for a chronic illness, you might find that it simply does not work. It can be quite disappointing to undergo discomfort and all of the testing only for the medicine not to be effective or for it to do very little for you. That is part of why most trials will caution their patients not to get their hopes up too much.
What’s the Verdict, then?
There are pros and cons to entering these sorts of studies, and the decision will rest with you as far as the potential risks go. Either way, though, the participants are part of important research that can benefit all of humanity! I give huge kudos to anyone who has been a part of them.
I think that this is fresh on our minds due to a lot of the vaccine trials that have occurred lately. Without those heroes who volunteered, where would we be right now?